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Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Sponsor
Kristina Gemzell Danielsson (Other)
Overall Status
Terminated
CT.gov ID
NCT01615224
Collaborator
(none)
23
Enrollment
1
Location
2
Arms
90
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Repeated Doses of Misoprostol for Treatment of Missed Abortion
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Oct 30, 2019
Actual Study Completion Date :
Oct 30, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: single dose

Patients receive the standard treatment with 800mcg of vaginal misoprostol
Experimental: repeated doses

patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment.

Drug: misoprostol
repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.
Other Names:
  • Cytotec 200mcg Pfizer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy [1 day]

      Complete abortion as judged by ultrasound

    Secondary Outcome Measures

    1. Acceptability [1 day, 1 week, 2 weeks, 3 weeks, 5 weeks]

      questionnaire on future choice of treatment method. Surgical or medical treatment if free choice. If having to have medical would she choose repeated doses or single dose?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus
    Exclusion Criteria:
    • empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Obstetrics and Gynecology, Danderyd Hospital Stockholm Sweden 18288

    Sponsors and Collaborators

    • Kristina Gemzell Danielsson

    Investigators

    • Principal Investigator: Kristina Gemzell Danielsson, professor, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristina Gemzell Danielsson, professor, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT01615224
    Other Study ID Numbers:
    • WMA11
    First Posted:
    Jun 8, 2012
    Last Update Posted:
    Dec 18, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Kristina Gemzell Danielsson, professor, Karolinska Institutet
    missed abortion
    miscarriage
    Additional relevant MeSH terms:
    Abortion, Missed
    Misoprostol

    Study Results

    No Results Posted as of Dec 18, 2019